Serina Therapeutics Secures FDA Support for Parkinson’s Trial, Plans Global Launch of SER-252

August 26, 2025

DENVER, Colo., Aug 26, 2025 (247marketnews.com)- Serina Therapeutics (NYSE:SER) is gaining momentum after announcing that the U.S. Food and Drug Administration (FDA) supports its registrational trial design for SER-252, an investigational treatment for advanced Parkinson’s disease, under the 505(b)(2) NDA pathway.

Following a Type B meeting with the agency, the FDA’s written feedback confirmed that Serina’s proposed study could form part of a registration-directed program, pending standard regulatory documentation. The company plans to file a U.S. Investigational New Drug (IND) application in Q4 2025, with U.S. enrollment expected to begin in Q1 2026.

SER-252 is a POZ-enabled formulation of apomorphine, aiming to deliver more consistent relief from motor fluctuations in advanced Parkinson’s patients. The trial will include a pharmacokinetic (PK) bridging component to an approved apomorphine product, aligning with FDA expectations for a 505(b)(2) submission.

Serina expects to begin dosing patients in Australia in Q4 2025, generating early data to contribute to the global registrational package. CEO Steve Ledger emphasized the goal to streamline development while maintaining scientific rigor and efficiency.

With the FDA feedback confirming its regulatory pathway, Serina now looks to accelerate SER-252 and its broader pipeline of POZ-enabled therapeutics, each potentially leveraging the same streamlined approval route.

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